COVENANT MEDICAL STAFF NEWSLETTER | DECEMBER 2012

CONTENTS Treating Cancer 2, 3 & 4 It’s More than Medicine A Culture of Safety = A Culture of Respect Dr. Kristin M. Nelsen, Covenant HealthCare Chief of Staff

5 Cancer touches us all, whether it is our patients, family, friends or ourselves. It is a Thoughts on Physician psychological battle as well as a physical one. Patient Satisfaction One of my high school classmates became a gifted surgeon and was diagnosed with pancreatic cancer, a tumor on which he had frequently operated on others. During 6 & 7 his illness, he recommended a book, Cancer: 50 Essential Things To Do, by and Fertility Greg Anderson which describes recovery from cancer by taking on a lifestyle of wellness – not just fighting an illness. He recommends paying attention to 8, 9 & 10 nutrition, exercise and attitude as well as emotional and spiritual support. Commentary on Yet another friend of mine was diagnosed with an inoperable brain tumor. Choosing Wisely® She is a young mother of five children, and had just sent her youngest off to Recommendations kindergarten. I am amazed by her strength and the ability to see the positive in life, despite her diagnosis. She was thankful that she had her seizure at night and not while driving her children, and grateful that the nurse taking 11 care of her after her brain biopsy was someone she knew. She was more A New Cancer Weapon: concerned with what to tell her children than what would happen to her. Antibody-Drug Conjugates She had faith in her care team. I hope that I would have that kind of inner strength. 12 & 13 Jimmy Valvano won the ESPY award in 1993 while battling cancer. mind Pelvic Floor Disorders He mentioned three things we should do every day: laugh, think and Fighting the “Taboo” have emotions that bring us to tears. Having a positive attitude is so important. We can live in the moment and find time to play and find joy. 14 & 15 Surgical Outcomes Research As physicians, we must remember we are healing partners. We Aiming For Better Patient Care can have empathy with our patients and in the process, we may learn something about ourselves. Contact is comforting. body Laugher is good medicine. Love, kindness and concern 16 are essential. The journey of wellness is much more than Taking Action on medicine: it involves the body, mind and spirit. Physician Engagement

Dr. Kristin M. Nelsen, Chief of Staff spirit A Culture of Safety = A Culture of Respect

GUEST AUTHOR Dr. Peter Bistolarides, Surgeon Champion for the Michigan Surgical Quality Collaborative, CMU College of Medicine – Department of Surgery

Recently, the Covenant HealthCare Surgical Quality Institute of Medicine (IOM), and co-author of the 1999 IOM Improvement Committee (SQIC) – which participates in report “To Err is Human: Building a Safer Health Care Sys- the Michigan Surgical Quality Collaborative (MSQC) – tem.” In it, the IOM addressed errors and patient safety in the commenced participation in MSQC’s Peri-Operative Initia- health care system. The report revealed that the U.S. health tive (POI). The POI is an initiative to look at peri-operative care system had a problem – a disturbing amount of errors procedures and processes, identify areas of improvement and inefficiency – and that the technology existed to address based on evidence and best practices, and validate by this. The goal: a reduction of errors in the system by 50% improved outcomes. While secondary goals such as patient within five years. experience, satisfaction and even cost are important, the POI and MSQC programs are anchored by a higher purpose – Leape described how there was great enthusiasm – and still the improvement of patient safety. The inaugural meeting is – in implementing all manner of procedures, tools and of the hospital’s POI group, whose membership includes mechanisms to address this problem. Yet, the early gains surgeons, OR nursing staff, administration, and safety and seemed to have leveled off and 13 years after the IOM report, quality staff, was held on October 16, 2012. there is still a lot of opportunity for improvement. This is the paradox: more systems and efforts in place to improve The source of the quote below is open to debate: it has been patient safety than existed in 1999, definite improvement in attributed to the 1st century philosopher Philo of Alexandria many systems and processes, and the desire and commitment as well as a 19th century pastor, John Watson, in addition to to continue to improve – yet efforts have stalled. Clearly, an Plato and others. It is true to say that the sentiment – or some improvement of systems is not enough. There is a piece of variation of it – can be found in many of the world’s religious the puzzle that is missing. and philosophical traditions. So, what does this quote have to do with the POI, MSQC or patient safety? A Dysfunctional Culture

The Great Paradox Leape presented the results of various surveys of nurses, medical students and patients, which paint a picture of a In April 2012, the MSQC held its first annual confer- high degree of dysfunction in health care, citing findings ence in Detroit. The keynote speaker was Dr. such as verbal abuse of nurses and other health care workers, Lucian Leape, former professor of surgery dissatisfaction by patients of care received, and disturbingly at Tufts University, a member of the – looking at the entry point of the health care system – a high rate of burnout in a survey of medical students (plus another that showed 4.4% of respondents have seriously considered suicide). Physicians surveyed about disruptive behavior were equally revealing – 11% reported witnessing this type of behavior daily. A full literature search of similar surveys will demonstrate that these findings are only the tip of the iceberg.

PAGE 2 In looking at the stalled rate of improvement in care, Leape proposed a hypothesis: disrespectful behavior is the root cause of the dysfunctional culture of health care.

It is important to point out that the concept of disre- spectful behavior includes what most people readily identify as disruptive behavior. Besides active disruptive behavior (including verbal abuse, humiliation, put-downs and similar acts), there is passive disrespectful behavior (acts such as ignoring calls, dismissive attitudes, non-com- pliance, refusal to cooperate or communicate). There is also system-related disrespect (hours, workload, conditions, non-participatory environment and so on).

There are very few among us that can claim to demonstrate exemplary behavior at all times and in all situations. Note that disruptive or disrespectful behavior is not the sole purview of physicians. It can be displayed by ANY member of the health care team. There is a tendency to dismiss or even accept disrespectful behaviors, and to look at them as transient “incidents.” Yet, this only introduces or perpetuates dysfunction in the overall system and affects people in profound ways – acutely and chronically.

When a Crisis Hits

In August 2005, Air France Flight 368 was carrying 309 pas- sengers and crew. It made a hard landing in Toronto during a violent storm, skidding off the runway into a ravine, crashing and bursting into flames. In January 2012, the cruise ship Costa Concordia, carrying 4,252 passengers and crew, ran aground off the coast of Italy and capsized within hours.

How many people perished in each accident – absolutely or proportionately? Thirty-two people perished in the Costa Concordia disaster and given the nature of the Air France crash, you would expect an even greater loss. Surprisingly, all 309 passengers and crew of the Air France crash survived with only a few minor injuries – all evacuated within 90 sec- onds of the crash and with the aircraft actively on fire!

In the Costa Concordia case, the order to abandon ship did not come until an hour after the accident – even with evi- dence that the ship was starting to list, and then it took nearly 6 hours to complete evacuation.

Why the difference? Was it a matter of training? Perhaps, but there was an even greater issue: the lack of communication and coordination from the Costa Concordia’s command and a disregard of duty and mission. What has been well publicized

Continued on page 4

PAGE 3 Standards of behavior and performance, and principles of good communication, will need to be applied across the board and find a home at all levels of the hospital.

A Culture of Safety continued from page 3 is the fact that the captain of the Costa Concordia was already The Challenge off the ship before serious rescue efforts were underway. The POI’s over-arching goal is simple: to improve the care While one can call it a miracle on a number of levels, at the of the surgical patient. As part of the initiative, data-driven most fundamental level the Air France crew executed their and methodical examination of our procedures and processes training and their roles as expected – even in the cramped will certainly occur. Addressing the missing piece of the confines of a burning airliner – with the pilot and co-pilot puzzle – communication and a culture of respect – must be being the last to leave. addressed. This, without doubt, will be the most challenging part of the initiative. There are many factors to be considered, such as working conditions, team relationships, economic The Adverse Effects of Disrespectful imperatives and personalities. A careful examination of team Behavior relationships and communication will take time and honesty. The process may even be uncomfortable at times. It will not be a simple matter of “being nice” to each other (though that What if the crew of Air France 368 refused to communicate doesn’t hurt). It is much more than that. with each other or follow procedures? With only seconds to make decisions and react, the result could have been This challenge is not limited to surgical services. It is not an catastrophic. We know nothing about the individual crew “asymmetric” issue limited to one profession, one department members of the Air France flight, any more than we know or even one hospital. Standards of behavior and performance, about the people we work with on a daily basis. Perhaps they and principles of good communication, will need to be ap- had their disagreements – or even hated each other. Even if plied across the board this were true, what and find a home at all is important is that levels of the hospital. the mission was kept in mind, the objec- As Covenant Health- tive of the moment Care, along with other was the only thing “There was communication and hospitals, embarks on that mattered, and the journey to being a everyone performed cooperation without barriers.” High Reliability Orga- as they had been nization – and espe- trained. There was cially in its increasing communication and role as a major teach- cooperation without ing facility for physi- barriers. cians and health care personnel of all kinds – Leape describes acute reactions to disrespectful behavior addressing team communication, disrespectful behavior and (psychological distress such as fear, anger, shame and confu- communication will be a critical part of those efforts. sion), which also clouds judgment and impairs thinking. Long term, there is the maladaptive behavior of avoidance Patients expect the team caring for them at some of the most (minimizing contact with the source; calling only when critical moments in their lives to communicate with each necessary). ALL of these reactions increase barriers to good other effectively and efficiently – without fail. As physicians, communication. More importantly, ALL of these may have a we must model that behavior to others and to those who are direct, negative effect on patient safety by hindering efforts depending on our leadership and mentorship. We should to identify system problems and make meaningful improve- expect no less than this when we ourselves become the ments. This is the hidden cost of disrespectful behavior and “passengers” in the system. dysfunction in the health care system.

For more information, please contact Dr. Bistolarides at 989.583.6993 or [email protected]. Sources are also available upon request.

PAGE 4 Thoughts on Physician Patient Satisfaction

Dr. Noel Lucas, Hospitalist and Chair of the Physician Patient Satisfaction Committee, Covenant HealthCare

Dr. Noel Lucas, a hospitalist at Covenant HealthCare, has participated on physician patient satisfaction committees at various hospitals. In the interview below, he shares his thoughts about how and why physicians can make a difference.

If physicians could change one thing to improve physician patient satisfaction, what would it be?

At the very least, we need to remember to stop, sit and talk to our patients to reinforce the perception that we truly care – which we do. It’s why we sacrificed all those years to go to medical school and residency. Sometimes, we just forget or we get hardened emotionally, so we breeze through our rounds but in the process – if we don’t give our patients quality time – we can leave behind a wake of confusion, hurt, anger or feelings of abandonment.

Adjusting our behavior doesn’t always require spending more time with the patient. It does, however, require spending “quality” time to increase the perception of care. For example, instead of standing up to talk to a patient, pull up a chair, have a conversation, listen and give them your undivided attention. This is the one behavior that can make a world of difference in physician patient satisfaction.

Why is physician patient satisfaction such a hot topic?

Because our top priority should always be the patient – they deserve a good health care experience regardless of prognosis. However, patient satisfaction is also critical to a hospital’s financial viability. Hospitals have known for quite some time that Medicare would start withholding up to 1% of reimbursement payments based on their quality scores, 30% of which is based on physician patient satisfaction. The policy was implemented this past October, and equates to around $850 million per year in total withheld reimbursements to hospitals across the United States – or $255 million for just the physician patient satisfaction component. For an individual hospital, not meeting standards can add up to millions of dollars per year in withheld reimbursements.

What is the trickle-down effect of losing money?

It’s like running a household – when you bring home less money, you don’t have as much to spend – so maybe you don’t buy that iPhone or extra car, or take that vacation. A hospital is no different. Anything that affects the long-term financial viability of a hospital can affect decisions on everything from technology, innovation and equipment, to recruiting and retaining top talent, to calibrating employee bonuses. It can also affect the health of local practices – many of which are attached to the success of area hospitals. The financial viability of a hospital also contributes to the economic success of the local community since quality healthcare is an important criterion for business investment. Plus, there is the element of employee morale too – we all want to be associated with a hospital and colleagues that we are proud of.

How else can physicians help?

We need to examine our behavior toward patients and adjust it when necessary, which is always easier said than done. You’ll often hear that it takes 21 days to form a new habit (behavior), but there is no magic number. What it takes is constant dedication to do the right thing – which is to respect patients and give them the time of day. That’s what they are paying for and what they expect, not just a successful procedure.

In her article in this issue of The Chart, Dr. Nelsen said, “As physicians, we must remember we are healing partners,” – and she is absolutely right. Part of the problem we are facing right now is that we aren’t always taught in medical school how to be respectful to our patients. More schools are starting to integrate this idea into their programs, but for those of us who are already practicing, we may need to rethink and recalibrate our approach to patients.

For more information, or to join the Physician Patient Satisfaction Committee, please contact Dr. Lucas at 248.219.6805 or [email protected].

PAGE 5 Endometriosis and Fertility

GUEST AUTHOR Dr. Steven Fettinger, Obstetrician and Gynecologist, Women’s OB-GYN, PC

Physicians treating women in their reproductive ages must be Endometriosis should also be suspected for patients who mindful of the symptoms of endometriosis. Early diagnosis display those symptoms and fail to respond to non-steroidal and treatment may prevent loss of fertility and avoid unnec- anti-inflammatory drugs and birth control pills. essary pain. Relief of symptoms can be achieved by multiple medical and surgical interventions, but often requires defini- tive surgery after childbearing is completed. Diagnosis & Stages

Below is a primer on endometriosis – along with some useful Endometriosis typically involves the and updates – to ensure the proper care of women during and sacral ligaments but can occur in other tissues, such as lung, after their reproductive years. breast and C-section incisions. There are many theories regarding cause, but the predominant theory is retrograde menstruation with implantation of viable endometrial cells in The Disease Defined the region.

Endometriosis is a common disease that affects 5 to 10% As with many diseases, endometriosis is classified into one of reproductive age women. It involves the presence of endo- of four stages as shown in the illustrations below.* metrial tissue in an abnormal location (outside of the uterine cavity). These endometriosis “implants” can invade normal The stage depends on the location, extent and depth of endo- tissue under the influence of menstrual cycle hormones. Each metriosis implants, the presence and severity of adhesions, month, inflammation from this ectopic causes and the presence and size of ovarian . pain and reactive scarring of the affected tissue. This invad- ing tissue, although acting malignant, is totally benign but can cause significant pain and problems with fertility if not caught early. STAGE 1 (MINIMAL) STAGE 2 (MILD)

Many women use medication to deal with their pain, and may also lose several days of work each month due to the disabling pain. The loss of productivity and income is enor- mous, plus the medical costs are substantial. Endometriosis is responsible for: n 8% of all gynecologic hospital discharges n Hospitalizing four out of every thousand women n Up to 40% of all

STAGE 3 (MODERATE) STAGE 4 (SEVERE) Symptoms & History

The risk of endometriosis is doubled for patients who have a family history of endometriosis. If your patients have a his- tory or show the following symptoms, be on the alert: n n n n Infertility

*Illustrations developed by S. Fettinger to document findings. Typical Lesion Atypical Forms of Powder-burn in a Utero-sacral Endometriosis Lesions Ligament Nodule Tobacco Stain Clear Bleb Fleshy Stellate Formation

PAGE 6 Two-thirds of endometriosis is diagnosed in Stages I and II, Treatment 24% in stage III and only 10% in stage IV. Severe involve- ment of other organs, such as bowel or bladder, usually Early treatment and intervention, of course, is always essential occurs in stage IV and may require extensive surgeries. to preserve fertility.

The clinical course of the progression of disease is highly Treatment modalities include conservative observation, surgi- variable with the majority of patients remaining at Stage cal management and medical management. After identifying I and II throughout their menstrual years and remitting in the lesions, most energy sources, including cautery, KTP laser, menopause. Note that a variation of endometriosis is adeno- CO2 laser and harmonic scalpel, can be used to cauterize or myosis. This is endometriosis within the wall of the uterus vaporize endometrial implants. causing the same pain symptoms but without the destructive n The use of the daVinci Robotic System’s improved 3-D properties of pelvic endometriosis. Ovarian endometriosis optics may help identify early atypical lesions. () is also common and can be suspected when n The use of computer image enhancement, such as seen on pelvic ultrasound. Olympus narrow band imaging, also aids in the identification of endometriosis. The cyclical nature of the symptoms differentiates endo- metriosis from many other pelvic disorders such as pelvic Both of these modalities are currently available at Covenant inflammatory disease, appendicitis, , ectopic HealthCare to identify endometriosis. Two different fiber- pregnancy, inflammatory bowel disease and renal stones. delivered CO2 lasers are currently being evaluated for use at Upon physical examination, pelvic tenderness, scarring of the Covenant HealthCare as well. uterus sacral ligaments or enlarged ovaries are often seen. When future childbearing is of concern, laparoscopic cautery Definitive diagnosis usually requires with a find- of endometriosis lesions or excision of lesions may give ing of endometriosis lesions present within the pelvis. The symptom relief and improved fertility. Suppressive medical typical powder-burn and utero-sacral ligaments nodule are the therapy is used after surgery when childbearing is postponed classic endometriosis lesion, but many atypical forms are or when the patient wishes to preserve the option of having now recognized as endometriosis. These include; tobacco additional children. stained lesions, bleb or clear lesions, fleshy lesions, stellate formations, spider webbing and peritoneal defects. Surgeons Birth control pills (in a continuous regime) and Depo-Provera should familiarize themselves with these newly recognized are used to suppress menstruation using hormones to mimic forms, especially for patients having pain (see photos below). pregnancy (pseudo-pregnancy). GRNH analogues/antagonist (Depo-Lupron) may be used to turn off hormones, preventing menstruation (pseudo-menopause). Research using anti- Infertility Treatment Success , such as those drugs used to treat breast cancer (Letrazole) is currently underway. Infertility may be the only symptom of endometriosis for some patients. Most theories of how it causes infertility relate When childbearing is not of concern, a hysterectomy with to inflammatory substances within the pelvis and distortion bilateral salpingo-oophorectomy may be indicated for extensive of pelvic anatomy secondary to scarring. disease. In the less severe cases, when conservative manage- ment (medical or previous laparoscopic cautery) fail, a hysterec- The four-stage classification system helps predict the success tomy with conservation of one or both ovaries may suffice. of traditional infertility treatments for endometriosis. Stage I and II: 70% success rate of pregnancy Stage III: 50% success rate of pregnancy Stage IV: 30% success rate of pregnancy Call to Action

In-vitro fertilization for endometriosis has a 60-80% success Endometriosis is a disease that afflicts millions of women range for all stages. The range of in-vitro success is more in our country, so most of us know someone afflicted with related to the patient’s age than the extent of disease. this disease. The tragedy is when the disease goes untreat- ed, as it can result in unnecessary pain and/or infertility. As physicians, let’s be mindful and ask the right questions, recognize the symptoms and be proactive in our approach. For more information, please contact Dr. Fettinger at 989.792.3100 or [email protected].

Endometriosis with Olympus da Vinci Robot System with

Spider-webbing Peritoneal Defect Peritoneal Defect Narrow Band Imaging CO2 Laser Through Fiber

PAGE 7 Commentary on Choosing Wisely® Recommendations

Dr. Michael Schultz, Vice President of Medical Affairs

In the September issue of The Chart, Dr. Schultz, Vice President of Medical Affairs, shared his thoughts about health care reform in an article, “Of Rationing and Waste.” This article also summarized the Choosing Wisely initiative of the ABIM Foundation to improve patient care and eliminate unnecessary tests and procedures, and provided examples of waste reduction for nine medical societies. Schultz has subsequently asked key medical experts to comment on each of the Choosing Wisely recommendations for each society. This is the first in a two-part series of “Commentary” articles reflecting physicians’ opinions.

NOTE: Choosing Wisely recommendations appear in black, expert’s opinions appear in blue.

American Society of Don’t initiate chronic dialysis without ensuring a shared decision-making process between patients, their families, and Nephrology their physicians. Mohammad A. Bashir, MD It is imperative that patients with CKD or ESRD be informed and educated about treatment options. Don’t perform routine cancer screening for Treatment options include transplant, in-center dialysis patients with limited life expectancies hemodialysis, peritoneal dialysis or no form of treatment. without signs or symptoms. Various dialysis companies provide treatment option In general, the younger dialysis patient who lacks signifi- training for patients and their families. For more cant comorbid disease and is a good transplant candi- information, contact a nephrologist. date will likely benefit from a screening mammography and the colonoscopy, particularly if there are significant family or personal risk factors for those cancers. In American Academy of Allergy, specific other cases, a dialysis patient at high risk of breast or colon cancer and at low risk of mortality with Asthma & Immunology end-stage renal disease (ESRD) may also benefit from a Michael McAvoy, MD mammography and colonoscopy. For the most part, how- ever, screening mammograms and colonoscopies are not Don’t perform unproven diagnostic tests, such recommended as routine procedures for dialysis patients. as immunoglobulin G (IgG) testing or an indis- criminate battery of immunoglobulin E (IgE) Don’t administer erythropoiesis-stimulating agents (ESAs) tests, in the evaluation of allergy. to chronic kidney disease (CKD) patients with hemoglobin Some of our nation’s best food allergists who wrote the levels greater than or equal to 10 g/dL without symptoms of 2010 National Food Allergy Guidelines for NIH stated anemia. that allergen-specific IgG4 is a “nonstandardized and I agree with this recommendation. unproven procedure.”

Avoid nonsteroidal anti-inflammatory drugs (NSAIDS) in Don’t order sinus computed tomography (CT) or individuals with hypertension or heart failure or CKD of all indiscriminately prescribe antibiotics for uncomplicated causes, including diabetes. acute rhinosinusitis. In cases where patients have to take NSAIDS, they need Most acute rhinosinusitis is viral and most will resolve to keep well hydrated. in two weeks without treatment.

Don’t place peripherally inserted central catheters (PICC) in Don’t routinely do diagnostic testing in patients with chronic stage III–V CKD patients without consulting nephrology. urticaria. I agree with the recommendation, but keep in mind that Unfortunately, a lot of patients think that if they have patients with CKD may need dialysis access in the future. chronic urticaria they must have an allergic trigger. Most For that reason, I suggest protecting their blood vessels chronic urticaria is non-allergic and patient education is by using only hand veins for blood draws and IVs. For paramount. IgE testing is not recommended unless their the same reason it is advisable to also use the dominant history implicates a specific allergen. arm for taking blood pressure.

PAGE 8 Don’t recommend replacement immunoglobulin therapy for In the evaluation of simple syncope and a normal recurrent infections unless impaired antibody responses to neurological examination, don’t obtain brain imaging vaccines are demonstrated. studies (CT or MRI). If IgG level is not <150mg/dl and genetically defined or A detailed history and physical examination are a suspected disorder, IgG replacement does not improve important in establishing a cause of syncope. Patients outcomes unless there is impairment of antigen-specific with true syncope have prompt return to baseline IgG antibody responses to vaccine immunizations or function. Consider further testing for suspected TIA, natural infections. stroke and seizure.

Don’t diagnose or manage asthma without spirometry. In patients with low pretest probability of venous Guidelines stress spirometry is essential in asthma diag- thromboembolism (VTE), obtain a high-sensitive D-dimer nosis, stratifying disease severity and monitoring control. measurement as the initial diagnostic test; don’t obtain imaging studies as the initial diagnostic test. A negative D-dimer study is diagnostically useful in American College of excluding VTE. The likelihood of VTE is low even in Physicians high-risk patients when the D-dimer is low (favorable and negative predictive value). Gregg McLean, MD Don’t obtain preoperative chest radiography in the absence Don’t obtain screening exercise electrocardio- of a clinical suspicion for intrathoracic pathology. gram testing in individuals who are asymptom- Most professional organizations recommend against atic and at low risk for coronary heart disease. routine chest x-rays in healthy patients. Consider a study A positive test result in a patient at low risk for coronary in older patients undergoing major abdominal surgery or artery disease (CAD) represents a greater likelihood patients with cardiopulmonary disease. of being a false-positive study. The United States Preventative Service Task Force recommends against screening for CAD in low-risk adults. American Academy of Don’t obtain imaging studies in patients with non-specific Family Physicians low back pain. Andrew Lafleur, MD • Provide a trial of conservative treatment first. • Most episodes of back pain are mechanical in nature Don’t do imaging for low back pain within the and self-limited in duration. first six weeks, unless red flags are present. • Consider earlier imaging for suspected fracture There are a couple of published guidelines, (trauma) neoplasm, infection or neurologic deficits. based on numerous studies, which recommend no imaging for acute low back pain within 4-6 weeks of onset. The vast majority of these patients (some 90%) will improve within this time frame with conservative measures alone.

Continued on page 10

PAGE 9 Choosing Wisely recommendations continued from page 9 Don’t routinely prescribe antibiotics for acute mild-to-moder- Don’t do computed tomography (CT) for the evaluation of ate sinusitis unless symptoms last for seven or more days, or suspected appendicitis in children until after ultrasound has symptoms worsen after initial clinical improvement. been considered as an option. I agree with this recommendation. The Infectious Disease Ultrasound is good in experienced hands and – only if Society of America guidelines delineate the specific it is equivocal – a CT should be done. This reduces CT symptoms suggestive of bacterial rhinosinusitis, which radiation exposure in the pediatric population. may require antibiotic therapy. Don’t recommend follow-up imaging for clinically inconse- Don’t use dual-energy x-ray absorptiometry (DEXA) screen- quential adnexal cysts. ing for osteoporosis in women younger than 65 or men Depending on the reproductive age or post-menopausal younger than 70 with no risk factors. age, adnexal cysts should be followed up on depending I agree with this recommendation; however, keep in on their size. ACR recommends 1cm as a threshold for mind that assessing each adult patient for fracture risk simple cysts in post-menopausal women. is important. The major risk factors are advanced age, prior fracture, long-term steroid use, low body weight, family history of hip fracture, smoking and excess alcohol American Society of intake. Clinical Oncology Don’t order annual electrocardiograms (EKGs) or any other Bei Liu, MD cardiac screening for low-risk patients without symptoms. There is no convincing evidence that routine cardiac Don’t use cancer-directed therapy for solid screening in low-risk, asymptomatic patients is of any tumor patients with the following characteris- benefit. Performing cardiac screening tests on these tics: low performance status (3 or 4), no benefit patients leads to harm (cost, overtreatment, invasive from prior evidence-based interventions, not eligible for a procedures, etc.). clinical trial, and no strong evidence supporting the clinical value of further anti-cancer treatment. Don’t perform Pap smears on women younger than 21 or This is standard practice. The exception: for some who have had a hysterectomy for non-cancer disease. patients with a poor performance status due to cancer- I agree with this recommendation. The 2006 American related symptoms, and there is a chance to cure the Society of Colposcopy and Cervical Pathology consensus cancer (such as lymphatic), we still give chemotherapy. guidelines led to major changes in the management of cervical disease in adolescents (minimal or no interven- Don’t perform PET, CT and radionuclide bone scans in the tion). Subsequently, numerous specialty societies jointly staging of early prostate cancer at low risk for metastasis. recommended routine cervical cancer screening to begin I agree with this recommendation. at age 21. Don’t perform PET, CT, and radionuclide bone scans in the staging of early breast cancer at low risk for metastasis. American College of I agree with this recommendation. Radiology Don’t perform surveillance testing (biomarkers) or imaging Sanjay J. Talati, MD (PET, CT and radionuclide bone scans) for asymptomatic individuals who have been treated for breast cancer with Don’t do imaging for uncomplicated headaches. curative intent. It is unnecessary and less likely to change Some high-risk patients do want doctors to perform the management or outcome. Of course, imaging studies for surveillance despite it not being incidental findings will lead to additional recommended by the ASCO. imaging and cost. Don’t use white cell stimulating factors for primary Don’t image for suspected pulmonary embolism (PE) without prevention of febrile neutropenia for patients with less moderate or high pre-test probability of PE. than 20 percent risk for this complication. CTA is very sensitive and specific for PE and moderate to I agree with this recommendation. high pretest probability adds to the diagnosis and man- agement of patient. Low pretest probability unnecessarily Please go to www.choosingwisely.org for specific informa- adds radiation and radiographic contrast exposure to the tion about the Choosing Wisely initiative, or go directly patients. to http://choosingwisely.org/?page_id=13 for the full list of recommendations. You can also contact Dr. Schultz at Avoid admission or preoperative chest x-rays for ambulatory 989.583.4103 or [email protected]. patients with unremarkable history and physical exam. This is helpful only in patients with known chronic cardiopulmonary diseases or acute cardiopulmonary. The ACR recommends in patients older than 70 years This is the first in a two-part series who have not had a chest radiograph within the last six of “Commentary” articles reflecting months. physicians’ opinions. Part two will be published in the next issue of The Chart.

PAGE 10 A New Cancer Weapon Antibody-Drug Conjugates

GUEST AUTHOR Dr. Jacob C. Ninan, Oncology/Hematology, Covenant HealthCare

The Holy Grail of cancer treatment is to kill cancer cells using noncleavable linkers such as thioether linkers. quickly and effectively with minimal collateral damage and Each linker is suited to different types of cancer. side effects. A new cancer weapon, antibody-drug conjugates (ADCs), is bringing us closer to that objective. The best ADC protein targets have abundant expression on the cancer cells and very limited expression on other cells. Patients whose tumors express high target levels are most The Potential of ADCs likely to benefit from ADC treatment.

ADCs combine the selective power of antibodies – which are the fastest growing class of targeted therapeutics, with Promising ADC Trials the termination power of highly potent chemotherapeutic (cytotoxic) agents – which are more effective at killing can- Currently, there are approximately 25 ADCs in oncology cer cells but lack the selectivity. ADCs are designed to guide clinical trials and even more in preclinical development. the delivery of cancer-killing drugs to a precise location, maximizing their impact without adversely affecting normal A few examples of ADC advances in the news include: tissues. n Brentuximab vedotin (Adcetris; Seattle Genetics) was FDA-approved in 2011 for the treatment of Hodgkin ADCs are comprised of three elements: a monoclonal Lymphoma and systemic anaplastic large cell lymphoma, antibody, a cytotoxic agent and a linker that connects the two representing the first new drug for Hodgkin Lymphoma together. The antibody is directed toward tumor cell antigens in more than 30 years. The recipe includes an anti-CD30 or overexpressed proteins on the tumor cell, binding to the antibody conjugated to the antimitotic agent monomethyl cell surface antigen. The ADC then enters the cell, releasing auristatin E (MMAE). the cytotoxic drug to kill the cell. Importantly, the drug is n Trastuzumab emtansine (T-DM1; Genentech) combines not released until it is in the cell where it can do its job and the anti-HER2 antibody trastuzumab (Herceptin) with a maximize its impact without compromising other areas of derivative of the cytotoxin, maytansine (DM1) to treat the body. aggressive HER2+ breast cancer. It is currently under review by the FDA for women with advanced breast can- cer that has progressed after treatment with trastuzumab. Key Areas of Progress T-DM1 selectively binds to HER2 receptors that are often overexpressed on tumor cells. Positive Phase II trials and While initial ADC trials had disappointing results, the past one positive Phase III trial were recently reported. At 25 years of technology development in every facet of re- one year, T-DM1 had better response and survival rates search is yielding excellent discoveries. Recent generations than capecitabine plus lapatinib. It shows significantly of ADCs are showing more promise in treating both earlier prolonged progression-free survival with less toxicity and later stage tumors. This is largely due to: and side effects. It is considered generally safer, despite n The selection of well-characterized antigens that serve producing higher rates of thrombocytopenia and liver as the target for the antibody. These antigens should be enzyme abnormalities. Given the positive results of many well-expressed on tumor cells when compared to healthy studies, a major shift in the treatment of HER2 cancers is cells. Blood cell cancers are often selected for study since imminent. malignant blood cells are more accessible to antibod- ies than solid tumors. B-and T-cell surface proteins are Many ADCs are in various stages of trials for a wide range of typical target antigens as they are often widely expressed. cancers, and research continues to optimize the success rates Other promising targets include the growth of new blood of this very promising therapy. vessels (angiogenesis) since it is a key symptom of inva- sive cancers. For more information, please contact Dr. Ninan at n Maximizing the killing potential of cytotoxic agents. 989.799.6110 or [email protected]. Source information ADCs enable the use of more potent doses of drugs than is also available upon request. used in standard chemotherapy, since the targeted cell can accept a higher dose. n Improving the stability of the linker to keep the ADC stable in the bloodstream, releasing the drug within the targeted cell and not prematurely. Hydrazone link- ers were the initial linker of choice. To improve stability, other chemistries have been developed, such as disulfide- based linkers and peptide linkers, with some companies

PAGE 11 Pelvic Floor Disorders Fighting the “Taboo”

GUEST AUTHOR Dr. Thomas Minnec, Gynecologist, Women’s OB/GYN, PC

An estimated one-third to one-quarter of women in the that support may occur with damage to the pelvic muscles, United States will suffer from a Pelvic Floor Disorder (PFD) connective tissue attachments or both. in their lifetime. As defined by the International Continence Society, PFDs include and urinary Pelvic organ prolapse (POP) can result from pregnancy, incontinence. labor, vaginal childbirth, advancing age, variations in skeletal structure, neuromuscular compromise, racial and While PFD was often considered a taboo topic to discuss, genetic factors, and connective tissue disease. COPD, more women today are seeking help earlier than in the past. obesity, constipation, deficiency, malnutrition and Despite this trend, many still hesitate to broach the topic with anemia may also play a role. Lifestyle issues such as work their physician so it’s important to empower adult female environment, heavy lifting and tobacco usage, and previous patients to speak up. pelvic surgery also may contribute.

This is critical not only because quality of life is at stake, but Anterior vaginal wall prolapse () is a bulging of the also because age increases the likelihood of getting a PFD, anterior vaginal wall and overlying bladder. Posterior vaginal and the population of women age 65 and older will double by wall prolapse () is a bulging of the anterior wall of 2030 according to the U.S. Census Bureau. However, the into the . Apical prolapse can consist of pre-menopausal women can acquire the condition too. either the uterus/ descending into the vagina or the top of the vagina prolapsing down ( or vaginal While PFDs are rarely life threatening, they can lead to vault prolapse respectively). chronic pain and significant emotional and social conse- quences. Because the pelvic floor supports reproduction, Management of POP and urinary incontinence (UI) includes urination and defecation, PFDs often affect urinary, colorec- both non-surgical and surgical options. tal and sexual functions, causing embarrassing situations. Non-surgical Management

Non-surgical management techniques may start with a simple observation for the asymptomatic or mildly symptomatic patient. Use of vaginal estrogen cream/tablets can help fortify vaginal tissue and alleviate irritative symptoms.

Pelvic floor muscle strengthening exercises (Kegel), bio- feedback (beyond Kegel), weighted vaginal cones or electric stimulation may be utilized in an office setting. For patients whose symptoms are more prominent, have not completed childbearing, decline surgical options, or are poor surgi- cal candidates, the use of vaginal pessaries – which are diaphragm-like devices – remains an excellent alternative to surgical repair.

The American Congress of Obstetricians and Gynecologists (ACOG) practice bulletin recommends pessary trial use prior to surgical management in patients. The use of pessaries dates back as early as the 5th century BC. They are generally made of an inert plastic or silicone and are either supportive or space-occupying, with some designed to address urinary incontinence, all with their own advantages and disadvantages. PFD Causes

Normal anatomic support of the pelvic floor structures is Surgical Management provided by the interaction between the bony skeleton, intact neuromuscular function, and adequate ligamentous and For patients who have failed conservative non-surgical man- fibromuscular fascial support structures. Pathologic loss of agement, the final option is surgical. Women have an 11%

PAGE 12 Age increases the likelihood of getting a PFD, and the population of women age 65 and older will double by 2030. lifetime risk of undergoing surgery for pelvic organ prolapse or urinary inconti- nence by the age of 80, with a 30% risk of a repeat operation over a four-year period.

Surgical correction approaches have evolved through a series of steps beginning with tradi- tional reparative techniques and progressing to the development of specific tools and minimally invasive techniques, the increased acceptance of biologic and syn- thetic grafts, and the subsequent development of surgical kits that can be applicable to patients with prolapse.

This evolution of surgical approaches has been swift, owing primarily to technological advances in materials and techniques. As a result, new potential complications, such as graft-related healing difficulties have become apparent. Being prepared to address these and other surgical com- plications is of great importance to the reconstructive surgeon.

Specialized Care

For specialized treatment, it is recom- mended that women consult with a gyne- cologist who specializes in PFDs. Physical therapists may also be called upon for pelvic floor strengthening exercises. While women are the primary sufferers of PFDs, men can contract the disorder too and should visit their urologist.

The primary line of defense, however, is the primary care physician. It is important to engage, diagnose and start a course of action as early as possible, before symptoms become worse or irreversible.

For more information, please contact Dr. Minnec at 989.792.3100. Sources are also available upon request.

PAGE 13 Surgical Outcomes Research Aiming For Better Patient Care

GUEST AUTHOR Dr. Aziz M. Merchant, Director of Surgical Research, CMU College of Medicine – Department of Surgery

In 2009, the Institute of Medicine (IOM) identified health Effect of Age and BMI on Mortality delivery and outcomes research as one of their top priorities and Morbidity in Elective and Emergent for investigation in the upcoming decades. These initiatives, referred to as Comparative Effectiveness Research (CER), General Surgery can take a number of forms, including systematic reviews and meta-analysis, data analysis of administrative databases, The prevalence of obesity establishment of prospective clinical databases and registries, and morbid obesity in the and randomized controlled trials. United States has grown exponentially. In The IOM defines CER as “the generation and synthesis of addition, the el- evidence that compares the benefits and harms of alternative derly population is methods to prevent, diagnose, treat and monitor a clinical expected to be the condition or to improve the delivery of care. The purpose of dominant age group CER is to assist consumers, clinicians, purchasers and policy by the year 2030. makers to make informed decisions that will improve health We hypothesized care at both the individual and population levels.” that increasing age and body mass index In addition to CER, another type of outcomes research was (BMI) have a synergis- identified as being vital to furthering the cause of evidence- tically negative effect on based medicine: Patient-Centered Outcomes Research morbidity and mortality in (PCOR). This research involves looking at the outcomes of elective and emergent general individual patients and establishing the best management and surgery (in other words, increasing treatment based on individual patient characteristics. patient risk). Patient data from the Michigan Surgical Qual- ity Collaborative (MSQC), encompassing almost 150,000 The Central Michigan University Surgery Program, in addi- patients, was analyzed. Patients underwent general surgery, tion to resident training, is engaged in surgical outcome and general anesthetic, were over 18 years of age and had a body quality improvement research efforts as part of its mandated mass index (BMI) between 19 and 60. A regression analy- educational and scholarly activity mission. The Surgery Pro- ses of 30-day mortality revealed that the interaction of BMI gram has undertaken serious efforts to increase the amount with age is positively associated with higher mortality with of scholarly activity through the assignment of a director of the combination of higher BMIs and age above 70. Models surgical research, collaboration with the CMU College of to predict morbidity revealed that age alone is a predictor of Medicine, and participation with the Covenant HealthCare morbidity, and that the general trend of increased BMI being Surgical Care and Quality Review (SCQR) Committee. predictive of morbidity is present predominantly after age 50. It was found that increasing age and a higher American Following is a sampling of projects that have been completed Society of Anesthesiologists (ASA) class were the highest by CMU faculty and residents, in collaboration with predictors of mortality. Covenant HealthCare. Analysis of Outcomes of Diabetic and Non-diabetic General and Vascular Surgery Patients

Pre-operative diabetic and glucose screening is becoming routine in many centers and may or may not be cost effective. The true effect of diabetes on surgical outcomes is really not known. This study was conducted to as- sess the effect of diabetes on outcomes for general and vascular surgery patients. The MSQC was utilized to analyze data for 141,000 patients who had undergone elective or emergent general or vascular surgery and had a documented diabetes status (non-insulin dependent with or without oral medication; insulin-dependent). Analysis of overall 30-day mortality for the entire sample revealed that neither non-insulin dependent diabetics (with or without oral medication) nor insulin-dependent diabetics were at

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increased mortality risk. However, when looking at 30-day decrease the overall morbidity, insulin-dependent diabetics undergoing number of Upper general or vascular surgery are at increased risk compared to Extremity VTEs non-diabetics. Ventilator dependence, weight loss, emergency (UEVTEs). Improve- case and a higher ASA class were most predictive of morbid- ment strategies included ity and mortality. This data will form the basis of efforts to education of the staff on the reduce adverse surgical outcomes in diabetic patients and the importance of Range of Motion cost-effectiveness of preoperative diabetic screening. (ROM) for patients with a central line or long-term venous access de- vice (such as PICC lines). This included Arms: The Forgotten Extremity mandatory nursing in-service “Venous Access Education” training, which included Many of the surgical quality indicators and collaborative im- IV insertion, dressing changes, line trouble provement processes have focused on prevention of Venous shooting, and partial occlusion declotting. Thromboembolism (VTE). The main focus, however, has been the prevention of VTE in the lower extremity, and little Since the process improvement education, the global if any targeting the upper extremity. Covenant HealthCare MSQC UEVTE rate decreased by 16% and for all of SQRC and MSQC data, along with National Surgical Quality Covenant HealthCare, a 37% decrease was noted in Improvement Program (NSQIP) data, clearly demonstrated the first three months after education and other measures that there was an opportunity to decrease our VTE O/E were implemented. To ensure the continued success of this (Observed/Expected) ratio in this study. project, the team continues to closely monitor the strategies implemented. Also, Venous Access Education has been A multi-disciplinary team was assembled to analyze the added to Covenant HealthCare’s nursing core education MSQC/NSQIP data, and Six Sigma process improvement program to ensure that new employees receive this valuable tools were utilized to develop and implement a plan to education.

Surgical outcomes research is here to stay, and will inform much of the evidence- based approach that will guide the management of our surgical patients.

Summary

Using the MSQC administrative database does have its as a High Reliability Organization is raised through presenta- drawbacks. First, it is a completely retrospective approach tion and publication of these studies. The first two projects to study design, and therefore will contain a certain amount listed have been accepted for presentation at the Association of study bias. Second, the data is collected in block samples for Academic Surgery in February 2013, while Dawn Grauf, from a number of different hospitals; therefore the interpre- CSCQR, of Covenant HealthCare, presented her work at the tation of data may not be appropriate for all populations. annual meeting of the MSQC in Detroit last April. However, in terms of its advantages, large study sample sizes can be analyzed, thereby helping offset some of the inherent In summary, surgical outcomes research is here to stay, and bias. It also allows us to ask and answer clinical questions will inform much of the evidence-based approach that will that many times cannot be answered through a clinical trial. guide the management of our surgical patients. In addition, outcomes analysis will become an increasingly important Besides addressing patient care and quality issues, the process for determining quality of the care provided by projects noted above have involved residents and medi- healthcare entities, and will play a large role in forging cal students, enhancing participation of residents in patient healthcare policy in the future. safety and outcome efforts at clinical sites of training – a major direction being taken by the Accreditation Council For more information, please contact Dr. Merchant at for Graduate Medical Education (ACGME). Furthermore, 989.583.6993 or [email protected]. Sources are also Covenant HealthCare’s profile as a teaching institution and available upon request.

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Taking Action on Physician Engagement

Dr. John Kosanovich, Vice President, Covenant HealthCare; CEO, Covenant Medical Group

After sharing the results of the Physician Engagement Survey at several physician meetings this Fall, a decision has been made to address the following improvement opportunities identified by our physicians: n Disruptive behavior is not tolerated at my organization. n I am kept informed of the organization’s strategic plans and direction. n This organization makes patient safety a priority.

Our goal at Covenant HealthCare is to create the most attractive environment for physicians to practice medicine.

You will be hearing more about how we plan to address these specific opportunities as action plans are developed and implemented.

For more information, contact Dr. Kosanovich at 989.583.7555 or [email protected].

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